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Oral pharmaceutical composition containing a combination pparalpha and a hmg-coa reductase inhibitor

a technology of hmgcoa reductase inhibitor and oral pharmaceutical composition, which is applied in the direction of drug composition, biocide, metabolic disorder, etc., can solve the problems of early rate-limiting step in cholesterol biosynthesis, increase the risk of mistakes or omissions in the intake of drugs, and achieve high bioavailability of all drugs

Inactive Publication Date: 2005-02-10
GALEPHAR M F
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015] The present invention relates to an oral pharmaceutical composition, containing a combination of effective amounts of at least one HMG-CoA reductase inhibitor derivative and ...

Problems solved by technology

This is an early rate-limiting step in cholesterol biosynthesis.
The main disadvantage of this double administration is that it complicates the posology for the patients and hence it increases the risk of mistakes or omissions in the intake of drugs.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0056]

mg / capsuleIngredientF1F2F3Simvastatin201512Fenofibrate200160160Gelucire 44 / 14 ®350300400Vit E TPGS203030Polyethyleneglycol 6000302030Butylhydroxyanisole0.080.040.08Propyl gallate—0.04—

example 2

[0057]

mg / capsuleIngredientF4F5F6Iovastatin151512Fenofibrate150150160Gelucire 44 / 14 ®—350—Gelucire 50 / 13350—400PEG 6000——20PEG 2000—2010Butylhydroxyanisole0.04—0.04Butylhydroxytoluene0.040.080.04

example 3

[0058]

Ingredientmg / capsulesemi-solid formulationFenofibrate160hydropropylcellullose95Gelucire 44 / 14 ®350PEG 600060uncoated tabletPravastatin12.5Mannitol70Lactose15Microcrystalline cellulose11.5Sodium starch glycolate9butylhydroxyanisole0.01Magnesium Stearate2Coating of the tabletAbsolute ethanol36.46Povidone7.29Talc3.64Triacetin0.607pro capsula una

[0059] The example 3 hereinabove describes a composition corresponding to the present invention wherein the fenofibrate is formulated as a semi-solid formulation and the pravastatin as a coated tablet formulation, the fenofibrate and pravastatin formulations being filled as a single composition in one single hard gelatin capsule.

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Abstract

Oral pharmaceutical composition containing, in the same pharmaceutical form, effective amounts of a HMG-CoA reductase inhibitor derivative and of a PPARa, especially fenofibrate. Also described is the use of some inactive ingredients which allow to improve the dissolution and / or bioavailability of the drugs from the said composition.

Description

BACKGROUND OF THE INVENTION [0001] Hypercholesterolaemia plays a crucial role in the development of atherosclerosis diseases in general and coronary heart disease in particular. The risk of progression of the atherosclerosis process to coronary heart diseases increases progressively with increasing levels of total serum cholesterol or low density lipoproteins (LDL) cholesterol at both the individual and the population level. [0002] The HMG-CoA reductase inhibitors are reversible inhibitors of the microsomal enzyme HMG-CoA reductase, which converts HMG-COA to mevalonate. This is an early rate-limiting step in cholesterol biosynthesis. Inhibition of HMG-CoA reductase by HMG-CoA reductase inhibitors decreases intracellular cholesterol biosynthesis, which then leads to transcriptionnally upregulated production of microsomal HMG-CoA reductase at cell surface LDL receptors. [0003] Subsequently, additional cholesterol is provided to the cell by de novo synthesis and by receptor-mediated up...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/00A61K31/216A61K45/06A61P3/06
CPCA61K9/2018A61K9/2054A61K9/4808A61K9/4858A61K9/4866A61K45/06A61K31/00A61K31/216A61K2300/00A61K31/22A61K31/235A61K31/365A61P3/06A61K9/0053
Inventor DEBOECK, ARTHURVANDERBIST, FRANCISBAUDIER, PHILIPPESERENO, ANTONIO
Owner GALEPHAR M F
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